Submit your application and dossier
Find out how to submit your prescription medicine application and dossier.
Certain information must be submitted to the TGA for prescription medicine applications to proceed to evaluation.
Before you lodge your application, make sure you read Mandatory requirements for an effective application
Key information for applicants
Guidance and resources
- GuidanceModule 1 of the CTD describes the administrative information and prescribing information for Australia to support the registration of a prescription medicine under section 23 of the Therapeutic Goods Act 1989 and the variation of the details of an ARTG registration for a prescription medicine under section 9D of the Act.
- Stability testing for prescription medicines
- Guidance 18: Impurities in drug substances and drug products
- Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
- General dossier requirements
- Dossier documents matrix: Module 1
- Dossier documents matrix: Module 2-5
- Submission dossier checklist for prescription medicines
Common technical document
- Australian electronic submission basics
- Electronic submissions
- AU eCTD specification: Module 1 and regional information
- eCTD AU module 1 and regional information
- Automation of validation of eCTD and NeeS sequences
Minor Variations (includes Cat 3, SAR, SRR, MEC, EOI Generics, 9D(2C) Notifications
- Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities | Therapeutic Goods Administration (TGA)